💼 About This Role

You'll lead the CMC sub-team for antibody-based radiopharmaceutical programs from preclinical through clinical supply. You'll develop integrated CMC strategies using Quality by Design principles to drive alignment across internal and external partners. This role offers the chance to impact first-in-human studies for innovative cancer therapies.

🎯 What You'll Do

• Develop and execute CMC strategies for radiopharmaceutical drug candidates.
• Lead the CMC sub-team and represent CMC within program governance.
• Own integrated CMC plan, risk register, and decision log.
• Coordinate with internal sites and external CDMOs for supply.
• Facilitate cross-functional team meetings and manage communications.

📋 Requirements

• 10+ years of radiopharmaceutical or biopharma CMC experience.
• 5+ years of CMC program management experience.
• Experience with biologics (monoclonal antibodies, bioconjugates) or radiopharmaceuticals.
• Knowledge of FDA and global regulatory requirements for IND/NDA/BLA.

✨ Nice to Have

• Experience managing alliance/partnership programs.
• Familiarity with ICH Q8-Q12 guidelines and QbD principles.
• Technical understanding of antibody manufacturing and radiochemistry.

🎁 Benefits & Perks

• 🏖️ Flexible Remote Work
• 🏥 Health Insurance
• 📈 Stock Options
• 💰 Performance Bonus
• ✈️ Travel Opportunities

📨 Hiring Process

Estimated timeline: 2-4 weeks · AI estimate

1. 1Recruiter Screen· 30 min
2. 2Hiring Manager Interview· 60 min
3. 3Technical Interview· 60 min